Foundation Guides & Documents
European QP Association
The EU Directives and the EU Guide to GMP define some detailed requirements to be met by the Qualified Person (QP). These requirements have been extracted from the relevant documents and are summarized in a Good Practice Guide developed by the European QP Association. A number of responsibilities as well as requirements for continuous training for QPs are not defined in detail in the EU Directive and Guides. This Good Practice Guide – considered a "living document" – gives recommendations to QPs. The Guide is available for download if you register for the Association.
Pharmaceutical Microbiology Group
The group was founded as Rapid Microbiological Methods (RMM) Working Group on 7 June 2006. It reviewed the current situation of RMM in Europe. In the following years it supported group members with current information about the development, implementation and validation of RMM. To move forward to a harmonised thinking, the group further provided literature lists, best practice papers and guideline lists on its website. Today the scope of the activity is broader. Therefore the group was renamed to Pharmaceutical Microbiology Group. Its paper/guidance document is available for download if you register for the Group.
ECA Guidelines for the Evaluation and Investigation of Microbiological Deviations
Chapter 1 - Deviation Handling of Microbiological Environmental Monitoring Excursions in Non-Sterile Pharmaceutical Manufacturing
Chapter 2 - Lab Investigations – Endotoxin Out of Specification (OOS)/ Out of Trend (OOT)/ Atypical Results Investigations
Analytical Quality Control Group
The ECA Working Group on Analytical Quality Control was founded in 2010 in order to generate a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE and OOT results. Version 2 of the ECA OOS SOP has already been available for all ECA members since 2013. Given the complexity of the topic, it was decided that the handling of OOT and OOE results need to be addressed in a separate guideline SOP, since there is both a lack of knowledge in the industry and a lack of guidance for trend analysis from the regulators in spite of increased regulatory interest in this area. The documents are available for download if you register for the Group.
Since the publication of FDA´s Process Validation Guidance in 2011, validation has become a life cycle approach with focus on process knowledge and process understanding based on scientific sound principles. In addition, with the revision of Annex 15 of the EU GMP Guide, the EU has also been moving to modern process aspects (e.g. life cycle approach). The ECA Guide wants to provide support to both regulators and industry. On one hand, the guide contains the main elements of the new approach ("what to do"). On the other hand, it also serves as a supporting guide for the implementation ("how to do"). The Guide is available for download if you register for the Group.
It is of key importance that medicinal products are not only manufactured in a high quality in accordance with Good Manufacturing Practices, but that the quality and integrity of these products are maintained throughout the entire supply chain up to the patient. This is where Good Distribution Practice (GDP) comes into play. The GDP Interpretation Guide was published jointly by the ECA Foundation GDP Association and the Pharmaceutical Quality Group (PQG). It’s intention is to help colleagues in industry with the implementation of the EU GDP Guideline. The Guide is available for download if you register for the Association.
ECA/PQG Guidance on the Interpretation and Implementation of European Good Distribution Practice &
ECA/PQG Guidance on the Interpretation and Implementation of European Good Distribuition Practice for Active Substances
The Code of Practice has been developed to support Responsible Persons according to EU GDP Guide 2013/C343/01. It provides information about the responsibilities and duties of RPs as well as recommendations for education and ongoing training. Finally an example of a job description should help RPs to define their role in the supply chain of medicinal products. This Guide is also available for download if you register for the Association.
Visual Inspection Group
This group’s best-practice-paper aims at highlighting best practices for carrying out 100 % visual inspection of medicinal products for parenteral use in the pharmaceutical industry. It should be seen as addition and supplement to the monographs of the different Pharmacopoeias. Visual inspections of medicinal products for parenteral use should detect any readily identifiable visible container defects and ensure constant quality of the product in terms of absence of particular matter and/or turbidity, and correct or uniform appearance of a lyo cake. The Guide is available for download if you register for the Group.
DI & IT Compliance Group
The best-practice-paper was originally developed by the ECA Data Integrity & IT Compliance Group’s Advisory Board. Much rather than a strict requirement document, this paper is intended to be a reference for controversial issues. The documents are available for download if you register for the Group.
Data Integrity Task Force
Data Integrity has become one of the most frequently observed GMP deviations in FDA and EU Inspections. This is why the topic is currently in the centre of attention of both regulators and industry. The ECA Guidance Document covers - among others - the roles and responsibilities of Corporate and Senior Management in Data Governance as well as the necessary Policies, Procedures and Processes. It further provides information on establishing criteria for Data Integrity and security of records based on ALCOA+Principles and on Auditing for Data Integrity and security of records. You need to be an ECA Member to download the documents.
Cannabis Working Group
Searching for answers to GMP and other regulatory questions is a time-consuming activity. The ECA Cannabis Working Group’s document – available exclusively at the respective events – is therefore intended to provide a source of information, summarizing GMP and other regulatory information and documents currently available on a global level. In addition, it provides useful comments and an Annex with further information. It is the intention of ECA ́s Cannabis Working Group to update this comprehensive collection regularly and to add new information on regulations and guidelines once they are available.
ECA Roadmap - GMP Requirements and Regulatory Information on Medicinal Cannabis (and CBD Products) - Version 1.0